RAPS CMC Workshop: Key Implications for Regulatory Professionals and Their Role as Business Partners

Chemistry, Manufacturing and Controls (CMC or Quality) is one of the three key areas (with Safety and Efficacy) that health authorities (HAs) consider for the review and approval of drug applications. Effective CMC strategies and execution may reduce regulatory burden, enable shorter review timelines, and support postapproval maintenance. This program will convey key CMC concepts, challenges and opportunities encountered by those working in regulatory strategy as well as those in functional areas who partner with regulatory to achieve business goals.

In addition to demonstrating technical proficiency related to CMC, regulatory professionals must also cultivate strong partnerships with internal and external functional areas in order to achieve their strategic and tactical goals. These partnering functional areas, including business development, operations, product development and product lifecycle management, play an integral role in product development. Regulatory’s ability to understand how these functional areas’ activities interact with and support CMC can have a considerable impact on an organization’s ability to successfully launch a new drug.

Primary areas of focus for this program include (1) knowledge and execution, (2) enabling business objectives and (3) pressing technical issues. Hot topics will be addressed by experts in the field to provide critical details and key take-aways. Both days will provide participants with opportunities to query the speakers, share experiences to promote mutual development, and engage with new colleagues for professional growth.